Subject preference comparison between Clobetasol propionate shampoo, 0.05 and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis - ND
- Conditions
- Scalp PsoriasisMedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis
- Registration Number
- EUCTR2006-003073-27-IT
- Lead Sponsor
- GALDERMA R D SNC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1. Male or female subjects, 18 years of age or older, 2. Subjects with moderate to severe scalp psoriasis defined as global severity score of at least 3 on a 6-point scale , 3. Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study oral contraception, IUD, systemic injectable or patch contraception, strict abstinence or partner had a vasectomy, 4. Females of non-childbearing potential, i.e., premenses, post-menopausal absence of menstrual bleeding for 2 years , hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, are not required to have a UPT at the beginning of the study, 5. Subjects who signed written informed consent prior to any study procedures, 6.Subjects willing and capable of cooperating to the extent and degree required by the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Subjects who need systemic treatment for their body psoriasis, 2. Subjects who are at risk in terms of precautions, warnings and contra-indication see package inserts and/or Investigator Brochure , 3. Female subjects who are pregnant, nursing or planning a pregnancy during the study, 4. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment, 5. Subjects with a washout period for topical treatment s on the scalp less than Corticosteroids 2 weeks All other anti-psoriasis medications including, but not restricted to vitamin D derivatives, retinoids, salicylic acid, urea, coal tar and anthralin 2 weeks UV-light therapy 2 weeks 6. Subjects with a washout period for systemic treatment s less than PUVA therapy 4 weeks Biological therapies e.g. alefacept, efalizumab, etanercept, infliximab 12 weeks Treatments other than biologicals with a possible efficacy on psoriasis such as acitretin, isotretinoin, methotrexate, cyclosporine, corticosteroid, hydroxycarbamide, azathioprine 4 weeks Treatment known to worsen psoriasis such as lithium, beta-blockers, antimalarials, ACE inhibitors 2 weeks NOTE unless subjects have been on treatment for at least 6 months and their psoriasis considered stable at study inclusion 7. Subjects with an history of adverse response either severe side-effects or corticoresistance to topical or systemic steroid therapy, 8. Subjects who plan to have intensive UV sun exposure during the study mountain sports, UV radiation, sunbathing, etc , 9.Subject with a condition or who is in a situation which, in the investigator s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject s participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to compare subject s overall preference between Clobetasol propionate shampoo 0.05 and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.;Secondary Objective: N/A;Primary end point(s): primary variable on PP and ITT population to be analysed on this study will be subjects overall preference at the end of period II
- Secondary Outcome Measures
Name Time Method